The Use of Peanut Ball in Labor in Obese Women

NCT ID: NCT05276947

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2023-08-13

Brief Summary

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The purpose of this study is to assess the efficacy of peanut ball use on labor process and maternal, neonatal outcomes in obese pregnant women.

Detailed Description

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After being informed about the study, all participants giving written informed consent, on the active phase of labor (cervical dilatation = 5 cm), the pregnant women in the experimental group will be provided with a position change lasting at least 30 minutes every hour with a peanut ball. The peanut ball will be used with a sheath that is changed for each participant. Pregnant women in the control group will be included in the study during the active phase of labor (cervical dilatation = 5 cm). No intervention will be made by the researcher. They will receive standard care by the service nurse.

Conditions

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Labor Long

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be an intervention group and a control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Peanut ball intervention

The experimental group. In the active phase of the labor (cervical dilatation = 5 cm), the peanut ball, which has a cover provided by the researcher and changed in each patient, will be placed between the knees of the participant for at least 30 minutes every hour, and a position change will be provided with the peanut ball in each time. The positions to be given with the peanut ball, semi sitting lunge, side lying, tucked, leaning forward, pushing and sitting position.

Group Type EXPERIMENTAL

position with peanut ball

Intervention Type OTHER

The experimental group will be positioned with the peanut ball until the end of the active phase of labor.

Control group

Standard care will be given to the control group without positioning with a peanut ball.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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position with peanut ball

The experimental group will be positioned with the peanut ball until the end of the active phase of labor.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Admitted for delivery
* Maternal BMI \> 30kg/m2 at admission
* Gestational age \> 37 weeks 0 days
* Singleton pregnancy
* Cephalic presentation
* Cervical dilatation less than 5 cm
* Turkish speaking

Exclusion Criteria

* Pre-pregnancy BMI \< 30kg/m2
* Gestational age \< 37 weeks 0 days
* Multifetal gestation
* Intrauterine fetal demise
* Musculoskeletal problems
* Receiving magnesium sulfate
* High risk pregnancies (Preeclampsia/eclampsia, cholestasis, intrauterine growth retardation, fetal anomaly, polyhydramnios or oligohydramnios)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Fulden Ozkececi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gulten GUVENC, PhD, RN

Role: STUDY_DIRECTOR

Gulhane Faculty of Nursing, University of Health Sciences

Locations

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Gulhane Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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PBinON

Identifier Type: -

Identifier Source: org_study_id

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